Biosafety Becomes Binding

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Oct 23, 2013 (3 years and 9 months ago)

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Biosafety Becomes Binding

Legal Aspects of Implementing the Cartagena Protocol



M
ARIE
-
C
LAIRE
C
ORDONIER
S
EGGER

F
REDERIC
P
ERRON
-
W
ELCH

C
HRISTINE
F
RISON
































Centre for International Sustainable Development Law (CISDL) 2010


Foreword



Professor Stephen Toope,

President, University of British Columbia (UBC)


[to be inserted]


Biographies of the Authors & Contributors



A
UTHORS


Prof. Marie
-
Claire Cordonier Segger

is Director of the Centre for International Sustainable
Development Law (CISDL) in Montreal, Canada, Affiliated Fellow of the Lauterpacht Centre for
International Law (LCIL) at Cambridge University, and leads the Environment and Sustainable
Development La
w Program of the International Development Law Organisation (IDLO) in Rome,
Italy. She serves as a Visiting

Professor at the University of Chile Faculty of Law, as co
-
editor of
the Cambridge University Press Series of Volumes on Implementing Treaties on S
ustainable
Development, and as Senior Research Director for Sustainable Prosperity, a policy research network
on the Green Economy. Through the CISDL and the IDLO, Professor Cordonier Segger provides
legal advice on the implementation of international sust
ainable development treaties to the United
Nations and to governments in Africa, Asia Pacific and the Americas.
With the UNEP
-
GEF
Biosafety Project, she helped to design regulatory assessment tools for biosafety, and assisted
countries in developing nation
al laws to implement the Cartagena Protocol on Biosafety.
She serves
on the Board of the International Law Association (Canadian Branch), on ILA’s Committee on
International Law on Sustainable Development, and on the CD Gonthier Legacy Commission. She
also

chairs the International Law on Sustainable Development Partnership under the auspices of the
UN Commission on Sustainable Development, is a Councillor of the World Future Council, and
lectures in several universities around the world. She has authored or

edited over eighty publications,
including fourteen books in three languages such as:
Sustainable Development in World Investment Law

(Kluwer Law International, 2010) and
Sustainable Development in World Trade Law

(Kluwer Law
International, 2005) with Dr
M. Gehring;
Sustainable Development Law: Principles, Practices and Prospects

(Oxford University Press, 2004) with A. Khalfan; and
Sustainable Justice: Reconciling Economic, Social and
Environmental Law

(Martinus Nijhoff, 2004) with H. E. Judge C.G. Weerama
ntry. She did her doctoral
studies in international law at Oxford University, holds a masters degree from Yale University, and
earned both civil and common law degrees from McGill University, among other qualifications, and
she works in English, Spanish an
d French, also basic Portuguese and German.


Frederic Perron
-
Welch

is a Legal Research Fellow with the CISDL Sustainable Biodiversity Law
Programme and student
-
at law at the Canadian Environmental Law Association (CELA). He
represented the CISDL at the 10
th

Conference of the Parties to the Convention on Biological
diversity and has interned at the Biosafety Division of the Secretariat of the Convention on
Biological Diversity. He is a Contributing Author on the Collaborative Partnership on Forests’
Global F
orest Experts Panel on the International Forest Regime and provides technical legal
support to the ABS for Africa Initiative. He has also worked on legal projects for the Canada Parks
and Wilderness Society (CPAWS), Citizens Against Strip Mining (CASM), E
ast Coast
Environmental Law Association (ECELAW), and the Living Oceans Society. He has a LL.B.,
Environmental Law (Dalhousie), M.A., History (Toronto) and B.A.
cum laude
in History (CUA). He
is fluent in English and French and understands some Spanish.


Christine Frison

is a Legal Research Fellow with the CISDL, and currently conducts joint Ph.D
research as an affiliated junior researcher at the Centre for Intellectual Property Rights (University of
Leuven
-
KULeuven
-
, Belgium) and at the Centre for Philo
sophy of Law (University of Louvain
-
UCLouvain
-
, Belgium). Her Ph.D is titled ‘
Towards Redesigning the Plant Commons: a Critical
Assessment of the Multilateral System of Access and Benefit
-
Sharing of the International Treaty on
Plant Genetic Resources for
Food and Agriculture
.’ She has served as a legal adviser to the Belgian
Federal Ministry of Environment, where she remains a member of the Belgian Access and Benefit
-
Sharing (ABS) Contact Group. She regularly serves on the Belgian ABS delegation in various

ABS
related international meetings between 2006 and 2009. In 2006, she

performed a national survey on
the use of genetic resources by Belgian users and on the degree of knowledge and application of
international biodiversity obligations by these users (CB
D and Bonn Guidelines) for the
Belgian
Federal Ministry of Environment in collaboration with the Centre for Philosophy of Law
(UCLouvain)
. She has also worked as a consultant for international organizations such as Bioversity
International (formerly the

In
ternational Plant Genetic Resources Institute,IPGRI, Rome) and the
International Development Law Organization (IDLO, Rome).
At the CISDL, she has conducted
research within the Sustainable Development Law on Biodiversity and Biosafety Programme and the
Prog
ramme

on
Sustainable Developments in Natural Resources Law
(with a focus on the
International Treaty on Plant Genetic Resources for Food and Agriculture). She worked on the
Biosafety Law Project of CISDL in collaboration with UNEP
-
GEF to design biosafety r
egulatory
assessment tools and assist francophone countries in developing national laws to implement the
Cartagena Protocol on Biosafety. Mrs. Frison reviewed more than 15 African countries’ National
Biosafety Frameworks (NBFs), and served as an independen
t legal expert to many NBFs Validation
Workshops. Mrs. Frison has represented CISDL in the Convention on Biological Diversity (CBD),
the Cartagena Protocol, and the Food and Agriculture Organization (FAO).

She is the author of several academic and non
-
aca
demic publications in the area of agricultural
biodiversity, biodiversity and biosafety international law and policy.
She holds an LL.B. (University
of Montpellier I, France), an LL.M. in Public International Law (
Free University of

Brussels
-
ULB
-
,
Belgium
) and in International and Trade Law (University of Lyon I, France), diplomas in American
Law (University of Lyon I, France) and English Law (Nottingham Trent University, UK), as well as a
B.A. in English and Italian (University of Montpellier III, France)
.
During her undergraduate
studies, she spent a year at the Nottingham Trent University as an Erasmus exchange programme
student.
Her working languages are French, English and Italian; she speaks fair Dutch, and has a
notion of German and Spanish.



C
ONTRI
BUTORS


Jennifer Bond

is a member of the legal research group

with the Biodiversity and Biosafety Law
Research Programme for the Centre for International Sustainable Development Law. Her research
interests in sustainable development law include the
ecological and socio
-
economic effects of illegal,
unregulated and unreported (IUU) fishing.

She is also published in the field of civil litigation.

Jennifer holds a B.A (Dalhousie) and a LL.B, Marine Law (Dalhousie) and is a member of the Nova
Scotia Bar
risters' Society.


Prof. Jorge Cabrera Medaglia

is Lead Counsel for International Sustainable Biodiversity Law with
the CISDL. He is Professor of environmental law in the Masters programme on environmental law
at the University of Costa Rica and was forme
rly a tutor for WIPO’s distance courses on intellectual
property. Prof. Cabrera also acts as a legal advisor to Costa Rica’s National Biodiversity Institute
(INBio) and is an international consultant in the area of intellectual property, biodiversity,
bio
technology, biosafety, access to genetic resources and benefit sharing for national and
international institutions such as UNCTAD, CBD, ECLAC, IICA, SICA, CCAD, IPGRI, CYMMIT,
REMERFI, CATIE, UNITAR, University of California, IUCN Environmental Law Center
in Bonn,
COSUDE, EU projects, IISD, CAF, USAID, TNC, IDB, ICTSD, PNUMA, and the Institute of
Economic Development of the World Bank, amongst others. In addition, he has served as co
-
chair
of the CBD’s Expert Panel on Access and Benefit Sharing, as Chairm
an of the Sub working Group
on IPR and Capacity Building during the 2
nd

meeting of the Working Group on Access and Benefit
Sharing in Bonn. He is a member of the Technical Expert Group on Certificates of Origin
-
Legal
Provenance
-
Source established by the C
BD in the context of the International Regime Negotiations
on ABS and of the TEG on terms, working definitions and sectoral approaches. He also served as a
member of the delegation to the WIPO Committee on Genetic Resources and Traditional
Knowledge and t
he Group of Like
-
minded Megadiverse Countries. Prof. Cabrera has published in
the areas of intellectual property rights, access to benefit sharing, biosafety, trade and environment,
and has participated in the drafting of biodiversity and ABS laws, negoti
ated ABS contracts and
developed environmental legislation in countries including Costa Rica, Nicaragua, Panama, El
Salvador, Chile, Dominica, Bhutan, Seychelles, Honduras, and Paraguay. He has also been a trainer
on ABS for several African Countries, inc
luding Benin, Kenya, Tanzania, Botswana and Nigeria. He
holds a B.C.L (University of Costa Rica), LL.M (University of Costa Rica), and M.B.A. (National
University of Costa Rica).


Papa Meïssa Dieng

is Professor of International Law at Universite Gaston Be
rger in Saint Louis,
Senegal, where he is Senegal Director of all McCormack/Gaston Berger projects, including the
innovative Saint Louis Region Multi
-
Function Community Resource Center. A specialist in
environmental law, Professor Dieng is deeply involved
in local development policy and ecological
policy.


David Duthie

is an ecologist with over 20 years of experience in working on environmental issues.
Before joining UNEP in 2000 he was a biology teacher and an environmental consultant specializing
in Envir
onmental Impact Assessment (EIA) of development projects. He is Regional Coordinator
for Central and Eastern Europe, UNEP
-
GEF Biosafety. Since joining UNEP he has worked closely
with the international Convention on Biological Diversity whose objective is
"the conservation of
biological diversity, the sustainable use of its components and the fair and equitable sharing of the
benefits arising out of the utilization of genetic resources". This has meant trying to become an
expert in all aspects of biodiversi
ty, ranging from molecular biology, population genetics, all aspects
of species biology and their interactions within ecosystems. In 2005, David transferred from
Nairobi, Kenya to Geneva, Switzerland to work with UNEP’s Biosafety Unit, which works with
de
veloping countries to develop and put in place regulatory systems that ensure that applications of
modern biotechnology do not have negative impacts on biodiversity.


Liina Eek
is by education a plant ecologist (PhD, Tartu University). Currently she is an
adviser of
nature conservation (especially issues connected to alien species) and biosafety to Estonian Ministry
of the Environment. During 2003
-

2005 she worked in UNEP Biosafety Unit in Geneva as task
manager of biosafety projects for Central and Easter
n European countries. She has worked for
different projects in Tallinn Technical University (UNEP/GEF biosafety project, projects on soil
metagenomics). She
is member
of the Advisory Committee for Genetic Modifications (advisory
body to the Government; cha
irperson 2000
-

2003). She is vice chairperson of Cartagena Protocol
Compliance Committee.

Currently her main task is drafting NBSAP, new umbrella law on
environment and also working on consultancy bases for UNEP, assisting developing

countries in
preparin
g biosafety projects. She also gives lectures on biosafety in Tallinn Technical University.
Additionally, she is currently finalizing her masters theses in theology in Institute of Theology, with
main topic being bioethics.


Martin Endicott
(LL.B. (Lond),
BCL (Oxon), LL.M. (Penn))

is a former research fellow with the
CISDL. Martin specializes in the resolution of international business disputes. He has acted as
counsel in numerous international commercial and investment arbitrations, as well as in litigat
ion
and mediation proceedings, and proceedings before the World Bank Administrative Tribunal. He
has worked on NAFTA cases, as well as bilateral investment treaty cases, involving claims for
expropriation and breaches of international fairness standards a
nd other treaty commitments. He
has published several articles on investor
-
state arbitration. He was admitted as a barrister (England
& Wales) in 1999 and is a Fellow of the Chartered Institute of Arbitrators.


Mai Fujii

is a Ph.D. candidate in internati
onal law at the Graduate School for International
Cooperation Studies, Kobe University, Japan. Since April 2010, she has been a research fellow at the
Japan Society for the Promotion of Science (JSPS). Her principal field of research is environmental
liab
ility in international law. The topic on which she currently focuses is the issue of liability and
redress under the Cartagena Protocol on Biosafety. She worked as an intern at the Biosafety
Division of the Secretariat of the Convention on Biological Dive
rsity (SCBD) in Montreal, Canada
from October 2009 to February 2010. She has considerable experience observing several MEA
meetings including the 4th Meeting of the Parties to the Cartagena Protocol on Biosafety (MOP
-
4)
and ‘liability and redress’ meetings

under the Protocol, as a member of the Kobe University
Research Institute on MEAs (KURIM), an academic NGO. She holds an LL.B and LL.M (Kobe
University, Japan).


Kathryn Garforth

is the Legal Officer for the Cartagena Protocol on Biosafety with the Secre
tariat
of the Convention on Biological Diversity. She works, in particular, on the handling, transport,
packaging and identification of living modified organisms and socio
-
economic considerations in
biosafety decision
-
making as well as liability and redres
s and compliance. Prior to joining the
Secretariat, Ms. Garforth worked with the Centre for International Sustainable Development Law as
a researcher and consultant in the areas of access to genetic resources and benefit
-
sharing, biosafety
and health. In t
his capacity, she led and participated in projects with Environment Canada, GTZ, the
International Development Research Centre, the International Development Law Organization and
the United Nations Environment Programme, amongst others. Ms. Garforth holds
an LL.B.
(Osgoode Hall) and M.E.S. (York).


Gregory Jaffe

is the Director of the Project on Biotechnology for the Center for Science in the
Public Interest (CSPI), an advocacy and educational organization that focuses on nutrition and
health, food safety,
alcohol policy, and sound science. Mr. Jaffe came to CSPI after a long and
distinguished career in government service.


He first worked as a Trial Attorney for the U.S.
Department of Justice’s Environmental and Natural Resources Division for seven years.


He then
moved on to become Senior Counsel with the U.S. EPA, Air Enforcement Division, before joining
CSPI to direct the Biotechnology project.


Over the last decade, he has been a strong advocate for
federal positions in federal court and frequently has

spoken publicly on behalf of EPA.


At EPA he
was awarded a bronze medal for commendable service, a special achievement award, and a gold
medal for performance.

His interest in biotechnology began early in his career when he wrote a law
review article on r
egulatory issues surrounding biotechnology and genetically modified organisms. In
the early 1990s, while at the Department of Justice, he advised the Assistant Attorney General on
biotechnology issues and worked with a federal interagency committee address
ing biotechnology
policy.


He is currently a member of the Pew Initiative on Food and Biotechnology’s Stakeholders
Forum and was a member of the University of Pennsylvania Bioethics Center’s GMO Consumer
Values Panel.


He has published articles on agricult
ural biotechnology in the
Christian Science Monitor
,
the Food and Drug Law Institute’s
Update

magazine, and the Environmental Law Institute’s
Environmental Forum

Magazine.


He also has spoken at over a dozen conferences addressing
agricultural biotechnolog
y issues, both in the United States and abroad.


He is a recognized expert
on the U.S. regulatory structure for agricultural biotechnology as well as consumer issues pertaining
to agricultural biotechnology.


Gregory Jaffe earned his BA with High Honors fr
om Wesleyan
University in Biology and then received a degree from Harvard Law School.




Alexandra Keenan

holds a B.A. (Political Studies) from Mount Saint Vincent University and an
LL.B. with a Certificate in Environmental Law from Dalhousie. She spent a semester studying law
at the National University of Singapore and is currently completing a Civil Law de
gree at the
University of Ottawa. She has long been active on food security and sustainable agriculture issues
and worked as a research assistant on issues related to marine species at risk and oceans governance.
Her areas of interest include biosafety and

biodiversity, indigenous environmental rights, and the
impacts of international trade law on agriculture.


Prof. Julian Kinderlerer
is professor of

Professor of Intellectual Property Law, University of Cape
Town and Professor of Biotechnology & Society,

University of Technology, Delft, The Netherlands.
He is a Member of the European Group on Ethics; Chair, Task Group on Public Perception of
Biotechnology, European Federation of Biotechnology; Former Director, Sheffield Institute of
Biotechnology Law and

Ethics Education. He was a member of the United Kingdom’s Advisory
Committee on Genetic Modification from 1983


2003, Advisory Committee on Releases to the
Environment 1990


1999, and UK Biotechnology and Biological Science Research Council
Bioscience
for Society Panel 2005
-

(strategic input on societal issues surrounding the conduct and
outcomes of research supported by BBSRC). He holds a BSc (with distinction in Chemistry); B.Sc
(Hons) (with First Class Honours)


University of Cape Town, and Ph.D


Biochemistry,
Cambridge University. He was also Specialist Adviser to the House of Lords Select Committee on
the European Union during its investigation into the Regulation of Biotechnology in Europe (1998
-
99); Seconded to the United Nations Environment P
rogramme during 2000 to devise programmes
to assist developing countries in implementing the Cartagena Protocol on Biosafety; and assisted in
writing the initial strategy on Biosafety of the Global Environment Facility. 125 countries are
involved in the De
velopment Project which helps to devise a National Biosafety Framework and a
further 12 in implementation projects implementing the Frameworks. Adviser to these projects since
2001; Involved in many projects supported by the Wellcome Trust and the European

Union in
relation to bioethics and BioLaw; and worked with UNEP, UNIDO, FAO and ICGEB in relation to
biotechnology Law and ethics.


Prof. Veit Koester

is an external professor at Roskilde University Centre in Denmark, visiting
professor at United Nations
University, Institute of Advanced Studies, Yokohama, and a guest
lecturer in international environmental law at Copenhagen University, Faculty of Law. He was
chairperson of the Compliance Committee of the Aarhus Convention, as well as chairperson of the
Co
mpliance Committee of the Cartagena Protocol on Biosafety until 1 January 2009, and he chaired
the Working Group of the Parties to the CBD which negotiated the Protocol. He was one of the
two vice
-
chairs of the CBD negotiating body and chaired its Working
Group II throughout the
negotiations of the Convention. Veit Koester is a member of the IUCN Commission on
Environmental Law and a member of the European Council of Environmental Law. He has
received, among others, the UNEP


Global 500 Award (1996) and th
e Elisbeth Haub Award
(ICEL and Pace University) for ‘Environmental Diplomacy for the Year 2000’.


Nizar Mohamed

has in
-
depth knowledge and extensive experience in environment and
development issues developed during a working career spanning more than 35 y
ears. This
experience includes technical assistance and capacity building projects in many parts of the world,
particularly in Asia and the Pacific, as well as working with the New Zealand Government. The
regional, national and local level projects he ha
s worked with were funded by bilateral (e.g. DFID,
NZAID) and multilateral agencies (UNDP, UNEP
-
GEF, FAO, IFAD and ADB). From 2001
-
2006
he was the Regional co
-
ordinator for Asia for the UNEP
-
GEF global project on “Development of
National Biosafety Framewo
rks” and coordinated national projects in 23 countries in Asia (East,
South, Central and West Asia) to help them develop national biosafety frameworks (NBF).


Freedom
-
Kai Phillips
:
is a member of the legal research group

with the Biodiversity and Biosafet
y
Law Research Programme for the Centre for International Sustainable Development Law.
His

research interests in sustainable development law include
renewable energy regulatory regimes,
international trade law, and biosafety. He is also a research analyst focusing on Green IT and
Business Intelligence issues for Info Tech Research Group. He holds an LL.B. from Dalhousie
University (Halifax, NS. Canada)
, a

M.A. in Diplomacy and International Relations from the
Whitehead School of Diplomacy, Seton Hall University

(South Orange, NJ.
USA) and a B.S
magna
cum laude

from Eastern Michigan University (Ypsilanti, MI. USA).


Thomas P. Redick

represents clients in

the high
-
technology and agricultural biotechnology
industry sectors with issues relating to regulatory approval, liability avoidance and compliance with
industry standards addressing socioeconomic and environmental impacts


particularly
“sustainability”
initiatives in agriculture and high technology. Before establishing a solo international
environmental consulting practice (
Global Environmental Ethics Counsel
) in 2005 in St. Louis,
Missouri, he was a partner chairing the technology risk management pract
ice for Gallop, Johnson &
Neuman L.C. He has held many leadership positions in the American Bar Association Section on
Environment, Energy & Resources (ABA
-
SEER) including Committees Agricultural Management,
International Environmental Law and Climate Cha
nge, Sustainable Development & Ecosystems. In
2008, Mr. Redick was appointed to represent ABA SEER (Agricultural Management) on the Council
for Agricultural Science & Technology (CAST). In 2009, he was the first attorney to be elected
President of CAST.


As grower association representative to the Global Industry Coalition, he
attends meetings of the Convention on Biological Diversity and the Cartagena Protocol on
Biosafety. He has over 24 years experience practicing environmental and intellectual proper
ty law.
He has a law degree and B.A with high honors from the University of Michigan.


Olivier Rukundo

acts as legal consultant for both WIPO and the ABS Capacity Development
Initiative for Africa. He is also a Senior Legal Research Fellow at the CISDL an
d has worked with
the CISDL as legal scholar for the past five years on joint appointment to the biodiversity and
international trade programs. His broader legal research interests include intell
ectual property law,
international trade law and internation
al environmental law.

He holds a joint LL.B./B.C.L. (McGill).


Christine Toczeck

is an Associate Fellow with the CISDL. She has worked with Human Rights
issues in non
-
governmental organisations, and as a Legal Consultant in the private sector. Her past
experiences include research in innovative technologies issues, such as biosafety
and biotechnology
at the United Nations Environment Programme (Biosafety Unit), and nanotechnology at the
Canadian Institute of Environmental Law and Policy. Ms. Toczeck is also assigned as an Analyst
Team Member of the Oxford G8 Research Group (2007
-
2008
). She is proficient in English,
Spanish, and Portuguese, and learning French. She has been involved with the CISDL since March,
2007. Her legal interests comprise international biodiversity and biosafety law, health issues, human
rights, climate change an
d international governance. She holds an M.A. in International Studies
(Barcelona), an LL.B (PUC
-
PR) and LL.M (University of Barcelona).


Worku Damena Yifru

is an environmental lawyer currently working on biosafety issues. He is a
Programme Officer for bi
osafety policy and law at the Secretariat of the Convention on Biological
Diversity under the United Nations Environment Programme. He, among other things, coordinates
activities of the Secretariat in support of the work of the Compliance Committee under t
he
Cartagena Protocol on Biosafety. He served as the secretary of the working group and its successors
established over the years since 2004 for conducting the negotiations on the international rules and
procedures on liability and redress for damage resul
ting from the transboundary movements of
genetically modified organisms.

Prior to joining the Secretariat in February 2001, he worked for 12 years on environment and
development issues at different Government positions in his native country, Ethiopia. He
was the
head of Policy and Legislation Department at the Environmental Protection Agency of Ethiopia. He
was once the Director of Ethiopian Conservation Strategy Initiative which resulted in the
development and adoption of the Environmental Policy of Ethio
pia. He coordinated the drafting of
the basic environmental laws of Ethiopia which were passed by the Government in 2002. He was a
member and a legal advisor of the Ethiopian delegation in a number of international environmental
negotiations, including t
he negotiations for the Cartagena Protocol on Biosafety, and the
International Treaty on Plant Genetic Resources for Food and Agriculture. Worku holds a masters
degree (LL.M.) in Environmental Law from the London School of Economics and Political Science
(1995) and bachelors’ degree in law (LL.B) from the Law Faculty of Addis Ababa University (1988).



Tomme R. Young

is a Senior Policy and Legal Advisor and Consultant with the International
Research Institute for Sustainability who is currently based in B
onn, Germany. Throughout her 25
years as a lawyer, she has developed a specialized expertise in many areas of environmental law and
policy. Internationally, Ms. Young has served as a special advisor on environmental and sustainable
development issues to f
oreign governments, under the auspices of several UN agencies, global
NGOs and other institutions. She has worked in many countries, published many articles, and
provided advice to global and national bodies on a variety of key environmental legal/policy
issues,
including GMOs, environmental certification, incentives, and conservation finance. She has advised
35 countries, in Europe, Africa, Asia, Oceania and the Americas, regarding legal and legislative issues
within the natural resource (forest and fish
eries) sectors, as well as environmental sectors and energy
development.

With regard to genetic resource issues, she has participated in negotiation of international and
regional agreements, and prepared advisory white papers on all sides of the issues,
including the
application of biodiversity, sustainable development, environmental protection, commercial,
resource development and conservation, and coastal zone management law in the context of LMOs
and genetic resources for the United Nations. She has b
een named by the Global Environment
Facility as the legal expert on international expert team tapped to perform the external evaluation of
UNEP
-
GEF’s implementation of the Cartagena Protocol and has led an international expert team
tasked by the UN Food an
d Agriculture Organisation to undertake the external evaluation of
international instruments and processes within FAO’s mandate. Ms. Young also serves as Editor of
Environmental Policy and Law (IOS Press) and has served as an adjunct professor in several
contexts, including at the University of San Francisco School of Law. She is a graduate of Hastings
College of the Law (1981), and the University of Southern California (1978). At Hastings, she
served as an editor of the Hastings International and Compar
ative Law Review.

Acknowledgments

We would like to express our gratitude to a large number of persons who contributed in various
ways to the publication of this book.

First, we are deeply indebted to every contributor for their expertise, knowledge, pat
ience and good
humour throughout this lengthy book project: Jorge Cabrera,
Papa Meïssa Dieng,
David Duthie,
Martin Endicott, Mai Fujii, Kathryn Garforth, Gregory Jaffe, Julian Kinderlerer, Veit Koester, Tom
Redick, Olivier Rukundo, Christine Toczeck, Worku

Yifru, and Tomme Young. We also sincerely
thank the United Nations Environment Programme’s Division of Global Environment Facility
Coordination for their trust in the CISDL during our collaboration on the National Biosafety
Framework Development Project
for the reviews of National Biosafety Frameworks in more than
40 developing countries between 2004 and 2007.

This book would not have happened without the support of the dedicated secretariat and members
of the Centre for International Sustainable Developm
ent Law, including Alexandra Harrington and
Patrick Reynaud, who contributed greatly to this project. Thanks are due in particular to Christine
Toczeck, for her commitment and back
-
up assistance when one of the editors was on maternity
leave; Kathryn Garfo
rth, Jorge Cabrera and Olivier Rukundo for their constructive advice and
valuable guidance; and especially, the members of the CISDL Legal Research Group


Jennifer
Bond, Robert Feldman, Alexandra Keenan and Freedom
-
Kai Phillips


for their enthusiastic an
d
helpful technical assistance on all of the book’s chapters.

We would also like to recognize the support of the Canadian Environmental Law Association
,
Centre de Philosophie du Droit, Université catholique de Louvain and of the Centre for Intellectual
Pro
perty Rights, Katholieke Universiteït Leuven, as well as the International Development Law
Organisation, Sustainable Prosperity at the Universitsy of Ottawa, the International Development
Research Centre,
and
the Lauterpacht Centre for International Law in

Cambridge University
.

This
book
came together during the International Year for Biodiversity and celebrates its goal of
further raising public awareness of the importance of biological diversity to human well
-
being. We
hope that
it
makes a significant co
ntribution to that effort.

Last but not least, we were encouraged all through the process with the love, support, and faith of
our families, in particular when we were under tight time pressure and constraint to work during late
nights. To everyone, we sin
cerely thank you.


About the CISDL


It is the mission of the Centre for International Sustainable Development Law (CISDL) to promote
sustainable societies and the protection of ecosystems by advancing the understanding, development
and implementation of i
nternational sustainable development law (SDL). The CISDL is an
independent legal academic research centre which has a close partnership with the McGill University
Faculty of Law. It works in cooperation with other Faculties of McGill University, the Uni
versité de
Montréal, the Université de Québec à Montréal and a network of developed and developing country
law faculties. It is guided in its work by a roster of distinguished experts in international
environmental, economic and social law, representing d
eveloped and developing countries, from
intergovernmental and non
-
governmental organizations, academic institutions and private practice.

Since the
World Summit for Sustainable Development

(WSSD) in Johannesburg, South Africa, the
CISDL has taken on a United Nations
-
sanctioned partnership to implement the WWSD outcomes
with regard to International Law for Sustainable Development, with the International Development
Law Organzation in Rome, t
he International Law Association in London, the United Nations
Environment Programme and the World Bank. The partnership reports annually to the United
Nations Commission on Sustainable Development. For further information, see www.cisdl.org.


Acronyms



AIA


Advance Informed Agreement

BCH


Biosafety Clearing House

BSWG


Open
-
ended Ad Hoc Working Group on Biosafety

CBD


Convention on Biological Diversity

CPB


Cartagena Protocol on Biosafety

CGFRA

Commission on Genetic Resources for Food and Agriculture

CISDL

Centre for International Sustainable Development Law

COP


Conference of the Parties

CM


Compliance Mechanism

EA


East Africa

EC


European Community

ECOWAS

Economic Community of West African States

EFSA


European Food Safety Agency

EIA


environmental impact assessment

ENB


Earth Negotiations Bulletin

EU


European Union

ExCOP

Extraordinary Meeting of the Conference of the Parties

FAO


Food and Agriculture Organization

GATT


General Agreement on Tariffs and Trade

GE


genetically engineered

GEF


Global Environmental Facility

GM


genetically modified

GMO


genetically modified organism

ICJ


International Court of Justice

ILA


International Law Association

ILC


International Law Commission

ILM


International Legal Materials

INBio


Instituto Nacional de Biodiversidad (National Biodiversity Institute)

ISAAA


International Service for the Acquisition of Agribiotech Applications

ISDL


International Sustainable Development Law

ITPGRFA

International Treaty on Plant Genetic Resources for F
ood and Agriculture

LMO


living modified organism

LMO
-
FFP

living modified organisms intended for direct use as food, feed, or for processing

MDG


Millennium Development Goals

NBF


national biosafety framework

NFP


National Focal Point

NGO


non
-
governmen
tal organization

OECD


Organization for Economic Co
-
operation and Development

PCA


Permanent Court of Arbitration

PIC


Prior Informed Consent

R&D


research and development

SPS


Agreement on the Application of Sanitary and Phytosanitary Measures

TRIPS


Agr
eement on Trade Related Aspects of Intellectual Property Rights

UNCED

United Nations Conference on Environment and Development

UNCLOS

United Nations Convention on the Law of the Sea

UNCTAD

United Nations Conference on Trade and Development

UNDP


United N
ations Development Programme

UNEP


United Nations Environment Programme

UNEP
-
GEF

United Nations Environment Programme Division of Global Environment Facility



Coordination

UNTS


United Nations Treaty Series

UPOV


Union for the Protection of New
Varieties of Plants

WHO


World Health Organization

WSSD


World Summit on Sustainable Development

WTO


World Trade Organization

Introduction

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Part I: Essentials of Biosafety and Sustainable Development Law

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1

Biosafety, the Cartagena P
rotocol & Sustainable Development

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Context

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The Cartagena Protoco
l and the Three Pillars of Sustainable Development
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Conclusion

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2

Implementing Sustainable Development through National Biosafety Frameworks

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the UNEP
-
GEF Biosafety Project
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Sustainable Development Aspects of National Biosafety Frameworks

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Conclusion

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3

Crafting National Biosafety Regulatory Systems

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Components and Characteristics of a Functional and
Protective System
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International Obligations Relevant to Biosafety

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Conclusion

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Part II: Sustainable Development Law and Policy on Biosafety

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4

Risk Assessment and Risk Management

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The Protocol’s Provisions on Risk Assessment and Risk Management

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Comparison of the Protocol to Other LMO Risk Assessment Frameworks

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Challenges in Implementing
Risk Assessment under the Protocol

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Conclusion

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5

The Decision
-
M
aking Procedures of the Protocol

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The Advance Informed Agreement Procedure

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The Procedure for LMO
-
FFP

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Advance Informed Agreement and Prior Informed Consent (PIC)

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Current Issues and Challenges Relat
ed to the Procedures

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Conclusion

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6

Handling, Transport, Packagi
ng and Information

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Overview of Approaches to HTPI Implementation
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Review

of Implementation Laws for HTPI

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Models for Implementation with Minimal Trade Disruption

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Conclusion

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7

The Question of Public Participation
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Public Participation and International Sustainable Development Law
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Challenging Public Participation in Biosafety Policy

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Global Public Perceptions on Biotechnology
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Conclusion

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8

Access to Information and the Biosafety Clearing House

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“Meta data”

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Search mechanisms
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Use of BCH data by
Importers/Exporters/Developers
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Initial Controversies and Underlying Objectives

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9

Socio
-
Economic Considerations, Biosafety and Sustainable Development

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History of Socio
-
Economics and Biosafety
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Biosafety Regimes and Socio
-
Economic Considerations
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Biosafety, Socio
-
Economics and Sust
ainable Development Law

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Conclusion

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10

The Compliance Mechanism: Development, Adoption, Content and First Years of Life
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Legal Bas
is of the Compliance Mechanism

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Development of the Compliance Mechanism

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Conclusion

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11

Biosafety, Liability and Sustainable Development

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International Law on Liability and Redress for Environmental Harm

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Negotiations on the Liabili
ty and Redress Regime

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Nagoya
-

Kuala Lumpur Protocol on Liability and Redress

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Complimentary Liability and Redress Rules

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Conclusion

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Part III: National Implementation of Biosafety Regulatory Aspects

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12

Legislative Options for

National Implementation

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Outcome Orientation: Is Legislation Required?

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Which Cartagena Protocol Tasks Are Mandatory?

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Non
-
Mandatory Provisions

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13

National Biosafety Regulatory Systems in Central and Eastern Europe

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Introduction

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Overview of biosafety policies of CEE countries that are EU Members

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Non
-
EU Countries (Including Candidate and Potential Candidate Countries)

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R
egulatory Systems

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Conclusion

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14

Implementing the Cartagena
Protocol in West Africa: National and Regional Activities
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WAEMU Biosafety Regulatory Systems

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Issues Raised During Legal Analysis of Draft Laws and NBFs

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Regional Analysis
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CILSS/INSAH Regional Biosafety Initiative

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Conclusion

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15

Comparative Analysis of the National Biosafety Regulatory Systems in East Africa
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Biosafety Regulatory Systems in Kenya, Tanzania, and Uganda

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Comparative Analysis
of

EA Biosaf
ety Regimes and the African Model Law

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Cooperation, Coordination, and Harmonization of EA Biosafety Regimes

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Conclusion

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16

The National Biosafety Regulatory Systems in Asian and Near East Countries

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Conceptual Framework

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Experiences in Asian National Biosafety F
ramework Development

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NBF: policy context

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Conclusion: “Learni
ng by doing”
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17

The Regulatory and Institutional Biosafety Systems in the Americas
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The Impacts and Challenges Faced in the Field of Agrobiotechnology

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Biosafety regulatory and institutional frameworks in the Americas

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Outline of the Leading Biosafety Trends in the Americas

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Conclusion

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18

National Experiences with Legislative Implementation of the Protocol

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General Policy
Approaches

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Mandatory Elements: Obligations to Other CPB Parties

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Legislation of Domestic Scope

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Conclusion

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19

The Costa Rican Legal Framework on Agricultural Genetically Modified Organisms

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The Phytosanitary

Protection La
w and Related Regulations
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Provisions of the Biodiversity Law

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Provisions related to
Environmental

Impact Assessment

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Provisions of Seed Law Nº 6289

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Provisions of the Organic Farming Law

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Labelling, traceability and lia
bility

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Claims made before the Administrative Environmental Tribunal

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Conclusion

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20

Innovations in Biosafety Law in New Zealand

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Regulatory System

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Strategic Vision
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Permitting Mechanism
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Information System

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Monitoring and Inspections, Enforcement and Compliance

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Conclusion

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21

Liability & Redress in Canadian Case Law:
Hoffman v. Monsanto Canada Inc.

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Introduction

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The Facts at Issue

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The Decisions of the Courts on the Causes of Action

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Underlying Concerns

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Conclusion

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Part V: Global Policy Trends in Biosafety

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22

Sustainable Development, Biosafety and International Law

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Development Paradigms Prior to Stockholm
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Initial International Policy
-
Making on Sustainable Development

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Sustainable Development Law of Relevance to Biosafety

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Regional and
Domestic

Implementation
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Conclusion

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23

Trade and Investment Implications of Implementing

the Cartagena Protocol

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Introduction

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Trade Regimes, Investment Rules and Biosafety Measures: Tools for Sustainable
Development?

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Des
igning New Biosafety Measures: Trade and Investment Considerations

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Strengthening International Legal Coherence for the Green Economy

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24

The Cartagena Protocol and the Regulation of Genetically Modified Food Aid

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What is

Food
Aid
?
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Application of the Protocol to Consignments of Food Aid

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Key Considerations for the Regulation

of Food Aid in Domestic Law

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Conclusion

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Conclusions

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